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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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Summary of Product Characteristics last updated on the eMC: 27/01/2012
SPC Zofran Injection, Flexi-Amp Injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   12-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

4.4

Update to Section 4.4 Special Warnings and Precautions for Use with regards to QT prolongation

4.8

Update to include Undesirable Effects to include additional information on QT prolongation, including Torsades de Pointes.

10

Updated date
Updated on 18/10/2011 and displayed until 27/01/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections Revised:

4.2 Updated with information on administration and dosage
4.4 Updated with information adenotonsillar surgery
4.5 Updated with information on interactions
4.8Updated with definitions for adverse reactions
4.9 Updated with information on the use of the ipecacuanha
5.1 Updated with information on paediatric population
6.2 Updated with information on infusion solutions
10 Updated with new date of revision of text
Updated on 16/08/2011 and displayed until 18/10/2011
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Date of revision of text on the SPC:   19-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section Amended


4.7 Sentence update to "Ondansetron has no or  negligible influence on the ability to drive and use machines. "

 
Updated on 21/01/2011 and displayed until 16/08/2011
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections updated:

4.7 Additional information added

10 Date updated
Updated on 20/01/2010 and displayed until 21/01/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   14-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 - Addition of the following sentence: "Mean bioavailability in healthy male subjects, following the oral administration of a single 8 mg tablet, is approximately 55 to 60%"
Updated on 14/01/2010 and displayed until 20/01/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   14-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.1 - PONV wording amended as part of paediatric workshare.

 

 

 
Updated on 29/10/2009 and displayed until 14/01/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 - Adults:

Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention of post-operative nausea and vomiting (PONV).

Paediatric Population:

Zofran is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged =6 months, and for the prevention and treatment of PONV in children aged =1 month.

Section 4.2 - entire section
Section 4.4 - Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.

Paediatric Population:

Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.

CINV:

When calculating the dose on an mg/kg basis and administering three doses at 4-hourly intervals, the total daily dose will be higher than if one single dose of 5mg/m2 followed by an oral dose is given. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials. Cross-trial comparison indicates similar efficacy for both regimens (section 5.1).

Section 4.5 -Use of Zofran with QT prolonging drugs may result in additional QT prolongation. Concomitant use of Zofran with cardiotoxic drugs (e.g. anthracyclines) may increase the risk of arrhythmias (section 4.4).

Section 4.8 - Paediatric population
The adverse event profile in children and adolescents was comparable to that seen in adults.

Section 5.1 - entire section
Section 5.2 - entire section
Section 10 - 14-Oct-2009
Updated on 30/04/2007 and displayed until 29/10/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10: Reformating of the date of revision
Updated on 26/10/2006 and displayed until 30/04/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To add special warning “transient ECG changes including QT interval prolongation” to section 4.4 Special Warnings & Precautions for Use.
Updated on 03/05/2006 and displayed until 26/10/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   12/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
For further information please contact GlaxoSmithKline on +44 (0)800 221441
Updated on 19/04/2006 and displayed until 03/05/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/10/2004 and displayed until 19/04/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 11/02/2003 and displayed until 22/10/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 11/02/2003 and displayed until 11/02/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 05/08/2001 and displayed until 11/02/2003
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/07/2000 and displayed until 05/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 26/04/2000 and displayed until 12/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 26/04/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ondansetron hydrochloride dihydrate